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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19)

Manufactured by Safecare Biotech (Hangzhou) Co. Ltd, China - www.safecare.com.cn 

Device identification number
1490
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), Influenza A, Influenza B
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
1.5 AU (1.5)
Calibration
evaluated
Crossreactivity
evaluated
Fp
2.96 % (COVID-19)
Fp
0 % FluB
Fp
0 % FluA
Fn
0.56 % (COVID-19)
Fn
0 % FluB
Fn
0.56 % (FluA)
Precision
evaluated
Accuracy
100 % (FluB)
Accuracy
99.54 % (FluA)
Accuracy
98.41 % (COVID-19:)
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
100 % (FluA)
Clinical Sensitivity
100 % (FluB)
Clinical Sensitivity
97.04 % (COVID-19)
Type of antigen
nucleoprotein
Notes
FP: FluA:0, FluB:0. FN: FluA:0.56%, FluB: 0. Accuracy: FluA:99.54%, FluB:100%. Clinical Sensitivity: FluA:100%, FluB:100%.

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements